New CMS Chief Donald Berwick: a Trojan Horse for Quackery?

On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit <a href="http://www.ihi.org/ihi">Institute for Healthcare Improvement </a>(IHI), which "exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a 'quality chasm'.” Dr. Berwick was one of the authors of that <a href="http://iom.edu/Reports/2001/Crossing-the-Quality-Chasm-A-New-Health-System-for-the-21st-Century.aspx">IOM report</a>. His IHI has been a major player in the patient safety movement, most notably with its "<a href="http://www.ihi.org/IHI/Programs/Campaign/100kCampaignOverviewArchive.htm">100,000 Lives Campaign</a>" and, more recently, its "<a href="http://www.ihi.org/IHI/Programs/Campaign/">5 Million Lives Campaign</a>."<br /><br />Berwick's CMS gig is a "recess appointment": it was made during the Senate's July 4th recess period, without a formal confirmation hearing---although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A <a href="http://www.boston.com/news/local/massachusetts/articles/2010/07/07/obama_bypasses_senate_for_new_medicare_chief/?camp=obnetwork">recent story</a> suggested that Obama made the recess appointment in order to avoid a reprise of "last year's divisive health care debate." The president had originally nominated Berwick for the position in April, and Republicans have opposed "Berwick's views on rationing of care," claiming that he "would deny needed care based on cost."<br /><br /><strong>A "Patient-Centered Extremist"</strong><br /><br />If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described "Patient-Centered Extremist." He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an <a href="http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.4.w555v1">article for <em>Health Affairs</em></a> published about a year ago, he explicitly argued against the "professionally dominant view of quality of health care":<br /><br /><br /><br /><blockquote>I think it wrong for the profession of medicine—or any other health care profession, for that matter—to “reserve to itself the authority to judge the quality of its work.” I eschew compromise words like “partnership.” For better or worse, I have come to believe that we—patients, families, clinicians, and the health care system as a whole—would all be far better off if we professionals recalibrated our work such that we behaved with patients and families not as hosts in the care system, but as guests in their lives. I suggest that we should without equivocation make patient-centeredness a primary quality dimension all its own, even when it does not contribute to the technical safety and effectiveness of care.<br /><br /><strong>A new definition.</strong> My proposed definition of “patient-centered care” is this: The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care.<br /></blockquote><br />Does this mean that Dr. Berwick would also eschew professional, i.e., expert, judgment in favor of patients' wishes? In a word, yes:<br /><br /><blockquote><strong>Evidence-based medicine sometimes must take a back seat. </strong>First, leaving choice ultimately up to the patient and family means that evidence-based medicine may sometimes take a back seat. One e-mail correspondent asked me, “Should patient ‘wants’ override professional judgment about whether an MRI is needed?” My answer is, basically, “Yes.” On the whole, I prefer that we take the risk of overuse along with the burden of giving real meaning to the phrase “a fully informed patient.”<br /></blockquote><br />Dr. Berwick is not so naive as this opinion might suggest. He envisions a "mature dialogue" in such a case, and argues that "if, over time, a pattern emerges of scientifically unwise or unsubstantiated choices...then we should seek to improve our messages..." He also admits that there might be an occasional patient whose demands are so unreasonable that "it is time to say, 'No'." That exception, he argues, should not dictate the rule.<br /><br />There are situations in which most civilized people would agree with Dr. Berwick's view of 'patient-centeredness'. In both the <em>Health Affairs</em> article and in his <a href="http://www.ihi.org/NR/rdonlyres/0B7E1957-A466-4134-907D-F9E2B0F9BDE0/0/BerwickYaleMedicalSchoolGraduationAddressMay10.pdf">recent address</a> to the 2010 graduating class of the Yale School of Medicine, he offered real examples of petty, arbitrary hospital rules causing unnecessary sorrow for patients and their loved ones. It is in such contexts that he makes a convincing case that health professionals ought to behave "as guests in their lives." In an interview for the <a href="http://www.nytimes.com/2009/06/04/health/04chen.html?_r=1">New York Times</a>, he argued:<br /><br /><br /><blockquote>We don’t have a standard of services or processes that are comfortable for patients. We have built a technocratic castle, and when people come into it, they are intimidated.<br /></blockquote><br />Nothing to disagree with there. To create that standard, moreover, would not undermine settled medical practice ethics---it would celebrate them, even as it rightly embarrasses the profession for having taken so long to do so.<br /><br /><br /><strong>Enter the Woo</strong><br /><br />Eschewing the scientific basis for modern medical practice, however, is another matter. In February of 2009, Dr. Berwick gave a 'keynote' address at the IOM and <a href="http://www.bravewell.org/">Bravewell Collaborative</a>-sponsored <a href="http://www.iom.edu/Activities/Quality/IntegrativeMed.aspx">Summit on Integrative Medicine and the Health of the Public</a>. He shared the podium with Mehmet Oz, Dean Ornish, Senator <a href="http://www.csicop.org/si/show/ongoing_problem_with_the_national_center">Tom Harkin</a>, and other advocates of pseudoscientific health claims. I wrote about the conference at the time, mainly to call attention to its misleading use of the term "<a href="http://www.sciencebasedmedicine.org/?p=399">integrative</a> medicine": literature emanating from the Summit characterized it as "preventive" and "patient-centered," whereas the only characteristic that distinguishes it from modern medicine is an inclusion of various forms of pseudomedicine.<br /><br /><br />I noticed that Dr. Berwick was on the speaker roster, which I found disappointing: I imagined that he had either gone over to the Dark Side or, perhaps, was sufficiently naive about the topic to have been duped; or, more likely, that he had cynically accepted the offer to further his ambitions. I didn't bother to listen to <a href="http://www.imsummitwebcast.org/">his speech</a> until the CMS appointment was announced a few days ago.<br /><br />It is troubling, to say the least. Dr. Berwick did not argue, as he had in the NYT piece, that "If we doctors feel a person is going to make unwise choices, we have to take on the responsibility of being teachers, educators and informers." Rather, he praised his fellow speakers, most of whom were spouting nonsense, for their "reach" and "eloquence." He praised the IOM for its "glorious record...in pursuit of better designs in health care...traditional, <a href="http://www.ncahf.org/articles/a-b/allopathy.html">allopathic </a>curative care and now migrating into this distinguished and important new arena." He mentioned homeopathy and acupuncture, not to wonder why they should be promoted as effective, but merely to warn that they will fail---presumably in some economic sense---if they try to compete with each other for reimbursement.<br /><br />Such language, and Dr. Berwick's very presence at the Summit, were a far cry from advocating "patient-centeredness." What they amounted to was a generous endorsement of pseudoscientific practices and of the socio-political movement that promotes them. Even granting some naivete on his part (he called himself "an amateur at this topic"), he must have known this. Such an endorsement, unlike tearing down the "technocratic castle," has ethical implications at least as profound as those that Dr. Berwick tacitly or explicitly relies upon to support his arguments for patient-centeredness.<br /><br /><strong>"Physicians have no Immunity to Moral or Ethical Constraints"</strong><br /><br />The relevant medical ethics treatises (reviewed <a href="http://www.sciencebasedmedicine.org/?p=169">here</a>) are in substantial agreement that it is unethical for physicians to prescribe scientifically implausible methods or to refer patients to other practitioners for the same purpose. They are also in agreement that it is unethical to prescribe a placebo to a patient while claiming that the treatment has specific biologic activity---a point that has been <a href="http://www.publications.parliament.uk/pa/cm200910/cmselect/cmsctech/45/45.pdf">vigorously argued in the UK</a> this year, with regard to homeopathy. These ethical tenets are not mere odes to nerdy, sciency thinking; they are matters of honesty and integrity---fundamental bases for ethical interactions between physicians and patients.<br /><br />In 1983, philosophers Clark Glymour and Douglas Stalker published <a href="http://www.ncbi.nlm.nih.gov/pubmed/6835298?ordinalpos=6&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum">an article</a> in the <em>New England Journal of Medicine</em> titled “Engineers, cranks, physicians, magicians.” They framed modern medicine as follows, comparing it to what was then called "holistic medicine" (the article is quoted extensively <a href="http://www.sciencebasedmedicine.org/?p=177">here</a>):<br /><br /><br /><br /><blockquote>Medicine in industrialized nations is scientific medicine. The claim tacitly made by American or European physicians, and tacitly relied on by their patients, is that their palliatives and procedures have been shown by science to be effective. Although the physician’s medical practice is not itself science, it is based on science and on training that is supposed to teach physicians to apply scientific knowledge to people in a rational way.<br /><br />The practice of medicine in the United States and in other industrialized nations is a form of consultant engineering...<br /></blockquote><br />That statement is just as accurate now---even more so, in this era of Evidence-Based Medicine---as it was nearly 30 years ago, even if some might find the likening of medicine to engineering displeasing. Nor is it at odds with almost any definition of "patient-centeredness," other than one that presumes that the patient's desires trump the physician's ethics:<br /><br /><br /><br /><blockquote>A physician engineer can act as consoler; nothing in either logic or social psychology forbids it. But certain combinations are impossible or extraordinarily unlikely. A physician engineer cannot honestly claim powers of magic or occult knowledge. The principles governing scientific reasoning and belief are negative as well as positive, and they imply that occult doctrines are not worthy of belief. Moreover, physician engineers have no immunity to moral or ethical constraints. On the contrary, they are by training and by culture enmeshed in a tradition of rational thought about<br />the obligations and responsibilities of their profession.<br /></blockquote><br />Dr. Berwick---if he really believes what his presence and words at the "Integrative Medicine" Summit imply---is playing with ethical fire. (If, as I hope, he doesn't really believe those things, he's playing with ethics of another kind). Will we begin to see pseudomedicine "integrated" into Medicare and Medicaid? That is certainly the expectation of <a href="http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=669&Itemid=189">those who observed</a> Dr. Berwick's performance at the Summit, and who appear intent to hold him to his word.<br /><br />KA<br /><br />Two other blogs that have addressed this issue are:<br /><br />Dr. RW: <a href="http://doctorrw.blogspot.com/2010/05/not-only-evidence-based-medicine-but.html">Not only evidence based medicine but science based medicine may take a back seat in Donald Berwick's vision for patient centered care</a><br /><br />Dr. David Gorski: <a href="http://www.sciencebasedmedicine.org/?p=6040" title="Dr. Donald Berwick and “patient-centered” medicine: Letting the woo into the new health care law?">Dr. Donald Berwick and “patient-centered” medicine: Letting the woo into the new health care law? </a>

New CMS Chief Donald Berwick: a Trojan Horse for Quackery?

On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwic...

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Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?

<span style="font-style: italic;">Meaningful use</span> before <span style="font-style: italic;">meaningful usability</span>?<br /><br />The Dept. of HHS today has released the final version of "Meaningful Use" rules on HIT, which can be seen here: <a href="http://histalk2.com/2010/07/13/meaningful-use-final-version-full-text/" rel="bookmark" title="Article about: Meaningful Use – Final Version Full Text">Meaningful Use – Final Version Full Text</a>.<br /><br /><div dir="ltr">By what category of diligence were the rules for "meaningful use" finalized on the same date that a NIST conference is being held on health IT "usability" ("<strong>Usability in Health IT: Technical Strategy, Research, and Implementation</strong>", <a href="http://www.nist.gov/itl/usability_hit.cfm" target="_blank">http://www.nist.gov/itl/usability_hit.cfm</a>), implying there's a problem with usability of these experimental devices physicians are supposed to "meaningfully use?"<br /><br />Don't take my word on the issue of usability problems...<br /><br />The <a href="http://sites.nationalacademies.org/NRC/index.htm">National Research Council of the National Academies</a> (considered the highest scientific authority in the U.S.) issued a 2009 report on HIT. In that report, presided over by noted HIT pioneers G. Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt), were findings that current HIT does not support clinicians' cognitive needs as <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">here</a>:<br /><br /></div><blockquote dir="ltr"><span style="font-weight: bold;">CURRENT APPROACHES TO U.S. HEALTH CARE INFORMATION TECHNOLOGY ARE INSUFFICIENT</span><br /><br />WASHINGTON -- Current efforts aimed at the nationwide deployment of health care information technology (IT) will not be sufficient to achieve medical leaders' vision of health care in the 21st century and may even set back the cause, says a new report from the National Research Council. The report, based partially on site visits to eight U.S. medical centers considered leaders in the field of health care IT, concludes that greater emphasis should be placed on information technology that provides health care workers and patients with cognitive support, such as assistance in decision-making and problem-solving. </blockquote><div dir="ltr"><br />How about HIT industry trade/"educational" group <a href="http://www.himss.org/">HIMSS</a> itself? I think reasonable people might conclude the technology is not ready for "meaningful use" on a national scale from their mid 2009 report:<br /><br /></div><blockquote dir="ltr" face="arial"><a href="http://www.himss.org/content/files/HIMSS_DefiningandTestingEMRUsability.pdf">Defining and Testing EMR Usability: Principles and Proposed Methods of EMR Usability Evaluation and Rating</a> (PDF)<br />HIMSS EHR Usability Task Force<br />June 2009<br /><br /><strong>EXECUTIVE SUMMARY</strong><br />Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, <strong>is lack of efficiency and usability of EMRs currently available.</strong> Achieving the healthcare reform goals of broad EMR adoption and “meaningful use” will require that efficiency and usability be effectively addressed at a fundamental level.</blockquote><div dir="ltr"><br />These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations.<br /><br /><span style="font-weight: bold; color: rgb(255, 0, 0); font-style: italic;">Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the </span><span style="font-weight: bold;"><span style="font-style: italic;"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">risks entailed</a>.</span></span></div><div dir="ltr"> </div><div dir="ltr"><span style="font-size:0pt;"><span style="font-size:0pt;"><span style="font-size:100%;">For crying out loud, talk about putting the cart before the horse</span><span style="font-style: italic;"><span style="font-weight: bold;"><span style="font-size:100%;">...</span> </span></span></span></span></div><br /><div dir="ltr" style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbxjl-AlGATfarPayjaUYkCOG4sUrulp4D88Nk7_z-eEbaWRl-xi1g0neGKWDhEL1w6-_-FCu4iBoJx9AUlU-bccaAmEcMfmGI1uoa4gTohjch5gzcx5tA9Ru-uMB0Mip6NE0PuUsfDXJ5/s1600/horse-cart.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5493460657310735298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhbxjl-AlGATfarPayjaUYkCOG4sUrulp4D88Nk7_z-eEbaWRl-xi1g0neGKWDhEL1w6-_-FCu4iBoJx9AUlU-bccaAmEcMfmGI1uoa4gTohjch5gzcx5tA9Ru-uMB0Mip6NE0PuUsfDXJ5/s320/horse-cart.jpg" style="display: block; margin: 0px auto 10px; width: 253px; cursor: pointer; height: 168px; text-align: center;" /></a><span style="font-style: italic;font-family:arial;font-size:85%;" >Something's very wrong here...</span><br /></div><span style="font-weight: bold;"><span style="font-style: italic;"><div dir="ltr"><br /></div></span></span><span><span>However, this situation is anything but humorous. </span></span><span style="font-weight: bold;"><span style="font-style: italic;"><span style="font-weight: bold;"><span style="font-style: italic;"><br /><br />How more "cart before the horse" can government get?</span></span><br /><br /></span></span><span><span>Poor usability promotes medical error. Medical error puts patients at risk of iatrogenic injury and death<a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html"></a>.</span></span><span style="font-size:100%;"><br /><br /></span><span><span>Are we are entering an era of cybernetic medical assault on our patients (and perhaps criminal negligence and <a href="http://en.wikipedia.org/wiki/Manslaughter">manslaughter</a>, a term I do not use lightly) through irrational exuberance in computing -- and through exuberance about the profits to be made by the HIT industry?<br /><br />Unless we <span>slow down</span> in our exuberance and recklessness on HIT diffusion, my fear is that we very well might be.<br /><br />-- SS<br /><br /><span style="font-weight: bold;">Addendum:</span><br /><br />Also see my followup July 14, 2010 post "<a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html" style="font-weight: bold;">Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records</a>."<br /><br />-- SS<br /><br /><br /></span></span>

Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?

Meaningful use before meaningful usability ? The Dept. of HHS today has released the final version of "Meaningful Use" rules on H...

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Health IT and 'High Regulatory Standards': Criminal Negligence for Implementing Defective Systems That Put Data in the Wrong Charts?

Over at the <a href="http://www.histalk.com/">HIStalk</a> blog (a blog whose owner remains anonymous, and who uses an ISP that does not reveal information that could be used to identify him, apparently out of fear of retaliation for controversial stories he posts), the following appeared:<br /><span style="font-size:130%;"><br /></span><blockquote><span style="font-size:130%;"><a href="http://histalk2.com/2010/07/10/monday-morning-update-71210/" rel="bookmark" title="Article about: Monday Morning Update 7/12/10"><span style="font-weight: bold;">Monday Morning Update 7/12/10</span></a></span><br /><br />From <strong>Holy Smoke</strong>: <span style="color: rgb(0, 0, 255);">“Re: Cerner. Misidentification incidents have been reported </span><span style="color: rgb(0, 0, 255);">with Cerner PowerChart and Millenium in hospitals in Indiana, Michigan, and others after a Cerner upgrade. Entries are placed in the wrong electronic chart and reviewed data is for the wrong patient.”</span> Unverified. I saw nothing in the FDA’s <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm" target="_blank">Maude database</a>, so if it’s happening, customers should file an experience report. </blockquote><br />While the reports are "unverified", I can add that the FDA MAUDE database would not show any data if this problem were recent, as I believe MAUDE contributions are reviewed by FDA before posting.<br /><br /><span style="font-style: italic;">(7/21/10 </span><span style="font-style: italic;">addendum</span><span style="font-style: italic;">: various sources confirm this occurred at a religious-denomination hospital chain headquartered in the Great Lakes region of the U.S.)</span><br /><br />However, as I wrote in Oct. 2009 at <a href="http://hcrenewal.blogspot.com/2009/10/out-policy-is-to-always-have-unabashed.html"><span style="font-weight: bold;">"</span>Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault</a>", the MAUDE database does contain some error reports from this vendor (one of the very few HIT vendors who actually file such reports) such as:<br /><br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=64345"></a><blockquote><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=64345">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=64345</a><br /><span class="hardbreak">Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities.</span><span class="hardbreak"> Defects in the Auto Launch functionality make it possible for a <span style="font-weight: bold;">mismatch of patient data. </span></span><span class="hardbreak"><span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"><br /><br /></span></span><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=946706">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=946706</a><br />Patient care delay. The issue involves functionality in cerner millennium powerchart office and powerchart core and affects users that utilize the powerchart inbox and message center inbox. In results to endorse or sign and review, if the user clicks ok and next multiple times in quick succession while attempting to sign a result or a document, the display could lag behind the system's processing of the action, and multiple results or documents could be signed without the user's review. In message center, when clicking ok and next or accept and next, or when deleting or completing messages and moving to the next task, a document could be signed or a message could be deleted without the user's review. <span style="font-weight: bold;">Results could be endorsed or documents could be signed without physician review, which could impact patient care.</span> Cerner received communication that a patient's follow-up care was delayed as a result of this issue. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"><br /><br /></span><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=753029">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=753029</a><br />Microbiology set up a program within the cerner computer system to automate the reporting system for hsv (herpes simplex virus)testing. The system was tested with the assistance of cerner and found to be working appropriately. <span style="font-weight: bold;">The new system was operational for approximately 3 weeks when it was determined that the first word of the sentence, "no" was inappropriately dropping off of the following sentence: "no herpes simplex virus type 1 or herpes simplex virus type 2 detected by dna amplification. "</span> as such, two of five patients were incorrectly informed that they had hsv before the error was detected. One had started an antiviral creme treatment. The other three did not have follow-up visits until after the correct results were determined. Cerner has looked at the program and has not provided an answer for the system issue. In the interim, the previous manual review and entry process is being used. <span style="font-weight: bold; font-style: italic; color: rgb(255, 0, 0);"></span><br /></blockquote><br />Assuming the current reports from anonymous whistleblower "Holy Smoke" are true, I note the following.<br /><br />My observations apply to any vendor and/or healthcare organization that puts defective HIT into use in patient care--<br /><br />At my April 2010 post "<a href="http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html">Healthcare IT Corporate Ethics 101: 'A Strategy for Cerner Corporation to Address the HIT Stimulus Plan'</a>", I'd written:<br /><br /><span style="font-weight: bold;"></span><blockquote><span style="font-weight: bold;">A profoundly disappointing lesson in the ethics</span> of the healthcare IT sector (and the B-schools as well) can be gleaned from the following, a paper written by a Cerner employee and two health industry colleagues for a <a href="http://www.fuqua.duke.edu/">Duke Fuqua School of Business</a> course.<br /><br />The course is "Health Economics & Strategy (<a href="http://www.fuqua.duke.edu/admin/stuserv/courseinfo/hlthmgmt326.html">HLTHMGMT 326</a>), Distance Executive MBA" (syllabus <a href="http://faculty.fuqua.duke.edu/%7Edbr1/teaching/syllabusWEMBA.pdf">here</a> in PDF) ... The paper is entitled<span style="font-weight: bold;"> </span><span>"A STRATEGY FOR CERNER CORPORATION TO ADDRESS THE HIT STIMULUS PLAN."</span><span style="font-size:100%;"><br /></span><br /></blockquote>The paper was scrubbed from the Duke Fuqua School of Business Site on or around April 16, 2010 but a cached copy is <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Aycock-Prasad-Stiber-Cerner-2009.pdf">available here</a>. In that paper what I believe is a <a href="http://www.answers.com/topic/combination-in-restraint-of-trade-2">combination in restraint of trade</a> was suggested:<span style="font-weight: bold;"><br /><br /><span style="font-weight: bold;"></span></span><span style="font-weight: bold;"><blockquote><span style="font-weight: normal;">This paper seeks to clarify these implications<span style="font-style: italic;"> [of the the economic 'stimulus' package - ed.]</span>, understand the strengths and weaknesses of various players in the industry and recommend a strategy for Cerner Corporation to maximize its profit from the stimulus package and thereby secure a dominant position in the HIT industry.</span><br /><br /><span style="font-weight: bold;">... We recommend that Cerner collaborate with other incumbent vendors to establish high regulatory standards, effectively creating a barrier to new firm entry.</span></blockquote><span style="font-weight: bold;"></span><br /></span>High standards? I have some suggestions regarding "high regulatory standards."<br /><br />I agree that high, in fact, the <span style="font-style: italic;">highest </span>regulatory standards should be upheld.<br /><br />I think I can safely state that a common regulatory standard in healthcare is that those involved in patient care, even peripherally, act with<span style="font-weight: bold;"> sound judgment</span> and with <span style="font-weight: bold;">patient well being</span> as a foremost concern. Those acting recklessly and dangerously might be found negligent in a civil sense, or if acting recklessly in a willful and knowing manner, might be found criminally negligent.<br /><br />Two descriptions of criminal negligence:<br /><br /><blockquote><a href="http://www.thefreedictionary.com/criminal+negligence">Criminal negligence</a> - (law) recklessly acting without reasonable caution and putting another person at risk of injury or death (or failing to do something with the same consequences).<br /><br /><a href="http://definitions.uslegal.com/c/criminal-negligence/">Criminal negligence</a> is conduct which is such a departure from what would be that of an ordinary prudent or careful person in the same circumstance as to be incompatible with a proper regard for human life or an indifference to consequences. Criminal negligence is negligence that is aggravated, culpable or gross.(PDF).<br /></blockquote><br /><span style="font-weight: bold;">It is damn well clear that electronic medical records systems must function without unpredictable data errors that put data into the wrong persons' charts, thus producing two errors and two possibilities for patient harm: </span><span style="font-style: italic;">an erroneous absence of appropriate data in one patient's chart, and an erroneous presence of inappropriate data in another's.<br /></span><span style="font-weight: bold;"><br /></span><span style="font-weight: bold;">This is not a theoretical argument open to debate, and this is not a drill.</span><span><br /></span><span style="font-weight: bold;"><br /></span>A recent IT-related data error involving <span style="font-weight: bold;">one single medication</span> nearly killed my relative.<span style="font-weight: bold;"><br /></span><span style="font-weight: bold;"><br /></span><span>In addition, the "<a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">learned intermediary</a>" excuse used to punt liability </span><span>onto physicians</span><span> and other clinicians for patient harm due to IT errors </span><span style="font-weight: bold;">does not apply here, and this is also not open to debate. </span><span>Physicians, even the most learned, are not clairvoyant; they should not be expected to know which chambers are empty and which chambers are loaded in a game of cybernetic <a href="http://en.wikipedia.org/wiki/Russian_roulette">Russian Roulette</a> with the data on their patients.</span><br /><span style="font-weight: bold;"><br /></span>Having an EMR maintain fundamental relational integrity, i.e., not place clinical data entered in good faith by trusting clinicians in another patients' chart, is not rocket science.<br /><span style="font-weight: bold;"><br /></span>Those who design, those who implement, and those who put into production (i.e., for use by physicians, nurses and other clinicians in the care of patients) any health IT "upgrade" without the <span style="font-weight: bold;">extensive</span><span style="font-weight: bold;"> </span><span style="font-weight: bold;">testing, testing and more testing</span> necessary to prove proper operation on such a fundamental point as maintenance of relational integrity (i.e., correct patient identity in data storage and retrieval) <span style="font-weight: bold;">knew, should have known, or should have made it their business to know</span> that doing so puts patients at risk of injury or death.<br /><br />Putting an "upgraded" software application with such fundamental defects into actual use in real, live patients care environments - for whatever reason, e.g., finances, vendor marketing pressures, meeting planned objectives and numbers, obtaining a bonus, etc. - reflects in my view:<br /><br /><blockquote>"... a departure from what would be that of an ordinary prudent or careful person in the same circumstance as to be incompatible with a proper regard for human life or an indifference to consequences."</blockquote><br /><span style="font-weight: bold;">Thus:<br /><br /></span>In upholding the highest regulatory standards, if patients are harmed or die as a result of this type of HIT snafu, <span style="font-weight: bold;">criminal charges</span> against the responsible IT, clinical and administrative personnel would be an appropriate remedy to this type of negligence.<br /><br />As I wrote at "<a href="http://hcrenewal.blogspot.com/2010/07/4-billion-military-emr-ahlta-to-be-put.html">$4 Billion Military EMR "AHLTA" to be Put Out of Its Misery?</a>", in my view as of 2010 legal actions are the only way that the domain of healthcare IT can be returned to a field <span style="font-weight: bold;">"of, by and for" clinicians</span>, instead of "of, by and for" those who live off the hard work of clinicians and their patients.<br /><br />-- SS<br /><span style="font-weight: bold;"></span>

Health IT and 'High Regulatory Standards': Criminal Negligence for Implementing Defective Systems That Put Data in the Wrong Charts?

Over at the HIStalk blog (a blog whose owner remains anonymous, and who uses an ISP that does not reveal information that could be used to...

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Hospitals' Star-Crossed Financial Engineering

And speaking of the costs of <a href="http://hcrenewal.blogspot.com/2010/07/failure-of-success-healthcare-when.html">financial maneuvering by hospitals</a>, the Wall Street Journal just reported on <a href="http://online.wsj.com/article/SB10001424052748704545004575353190698790172.html">"Hospitals' Wall Street Wounds,"</a><br /><blockquote>Hospitals nationwide are tangling with Wall Street to get out of <em>disastrous wagers that have complicated their financial problems.</em><br /><em><br /></em><br /><em>Some hospitals are paying millions of dollars in penalties to get out of derivatives contracts, after betting incorrectly that interest rates would rise. Other hospitals are paying higher interest rates. At many, these ill-fated financial bets have contributed to layoffs and scuttled projects. </em><br /><em><br /></em><br /><em>More than 500 nonprofit hospitals—at least one in six—bought interest-rate "swaps" in a bid to lower their borrowing costs,</em> estimates Municipal Market Advisors, a Concord, Mass., consulting firm. The swaps allowed hospitals to act much like homeowners switching from a floating-rate mortgage to fixed-rate one, betting on rising interest rates. <br /><br />For a fee, the hospitals received a fixed rate to sell bonds, lower than the municipal-bond market at the time. These bets backfired when the Federal Reserve cut interest rates to nearly zero from more than 5% in 2007.<br /><br />Hospitals also issued auction-rate securities—which reset bond prices weekly or monthly through auctions—that represented about a third of the $330 billion market for these derivatives. Hospitals paid Wall Street firms more than $120 million in fees for the securities between 2005 and 2007, said data firm Thomson Reuters. That market dried in the 2008 financial panic, leaving hospitals with higher interest rates.</blockquote><br />The article included a few pointed examples, e.g.,<br /><blockquote>In April 2007, Smith Barney brokers pitched Tri-City Medical Center in Oceanside, Calif., on ways to save money on interest rates. In a presentation, the brokers argued that the hospital could save tens of millions of dollars by refinancing its debt with derivatives from parent Citigroup, according to a lawsuit filed in April 2010 against Citigroup and Smith Barney, now co-owned by Morgan Stanley.<br /><br />'Historically low' interest rates created an 'optimal environment,' according to Citigroup documents reviewed by The Wall Street Journal. 'Citigroup can mitigate the primary risks,' according to a slide presentation.<br /><br />Persuaded that it could cut its interest rate—5.7% at the time—on $67 million in outstanding bonds, the hospital issued auction-rate securities and added interest-rate swaps, according to the lawsuit and Daniel Callahan, an attorney for the hospital.<br /><br />Soon, the auction-rate market collapsed. Investors stopped bidding on these securities and the banks that sold them stopped acting as a buyer of last resort as they had in the past. This forced many hospitals and other issuers to pay a maximum penalty rate—sometimes up to 20%—that kicks in if there aren't buyers.<br /><br />As a result, <em>rates shot up to 17%, costing Tri-City some $16 million more than it would have paid under its old rates</em>, according to the lawsuit, filed in California Superior Court in Orange County.<br /><br />The hospital board replaced many top officials and paid Citigroup more than $6 million to get out of the auction-rate securities and the interest-rate swaps, Mr. Callahan said.<br /><br />The loss 'continues to impact Tri-City's ability to meet the needs of the entire community,' Mr. Callahan said, delaying the expansion of services and capital improvements.<br /><br />Auction-rate securities 'were an engineered, artificial market supported by the activities of the investment bankers designed to postpone a collapse,' the hospital alleges in the lawsuit.</blockquote><br />At least one financial expert agreed:<br /><blockquote><em>'Financial engineering by Wall Street has been a huge part of hospital's financial problems</em> and has even translated into a lack of hospital beds,' said Brian McGough, a managing director of health-care investments at Bank of Montreal Capital Markets in Chicago.</blockquote>This is another example of how health care organizations, including respected not-for-profit institutions, jumped headlong into the transactions first economy of the last 20 plus years.  The were lured by the prospect of making easy money from financial transactions.  However, it looked like those who really made money were the middle men who sold everyone on the magic of derivatives.<br /><br />You would have thought that the highly compensated financial wizards that hospitals and other health care not-for-profits chose for their leaders in the last 20 plus years would have been able to see through such nonsense.  Why were they paid so much, if not for expertise in this area?  But I would suspect that they too became distracted by all the money floating their way to think about how it might end.  <br /><br />We have often decried the problems of<a href="http://hcrenewal.blogspot.com/search/label/ill-informed%20management"> ill-informed health care leaders</a> who do not have direct experience in actually providing health care, or much sympathy for the values of health care professionals.  <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-breaking-physicians.html">Breaking the medical "guild,"</a> and putting professional managers in charge of health care was once touted as a way to control costs.  It is ironic that after  health care organizations became sold on the uncanny abilities of managers with business, usually finance or marketing training, these geniuses turned out to be as gullible about the wonders of Wall Street as everyone else. 

Hospitals' Star-Crossed Financial Engineering

And speaking of the costs of financial maneuvering by hospitals , the Wall Street Journal just reported on "Hospitals' Wall Street ...

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The Failure of "Success Healthcare" - When Financial Maneuvering Takes Precedence Over the Health Care Mission

In the last few years, it seems that the whole world got tangled up in a web of complex financial dealings that mostly benefited those moving the money and paper, but often harmed everyone else.  So it should be no surprise that health care was similarly affected.  <br /><br />A <a href="http://www.stltoday.com/news/local/metro/article_03dce44e-8359-5bce-98f5-404949282a1b.html">story</a> from the St. Louis Post-Dispatch provided an illustrative case.  The news article began discussing the current difficulties of two local St Louis hospitals, then provided an explanation in what amounted to a series of flashbacks. Let me re sequence it a bit, starting with the background of two local hospitals that got caught up in web.<br /><br /><strong>Background</strong><br /><blockquote>For several decades, Forest Park Hospital — founded in 1889 as Deaconess Central Hospital — was one of the city’s leading community hospitals, serving a broad spectrum of patients including many African-American residents from north St. Louis.<br /><br />But in recent years, the hospital’s revenues and its number of patient visits had waned because, in part, of the emergence of major hospitals in west St. Louis County and its decision in 2006 to discontinue obstetric services.<br /><br />As the hospital struggled, it continued to be passed along from one owner to the next. In 2004, <em>it was acquired by Argilla Healthcare Inc. Argilla merged with Doctors Community Healthcare Corp. of Scottsdale, Ariz., which became Envision Hospital Corp</em>.<br /><br />Former board member Buford said Forest Park’s downfall began several years ago when <em>Envision executives made the decision to use the hospital’s profits to help prop up a faltering hospital that Envision owned in Washington</em>.<br /><br />In 2005, Envision sold the buildings and land of Forest Park Hospital and St. Alexius Hospital to Medline Industries, the Illinois manufacturer of surgical supplies.</blockquote><br /><strong>How the Hospitals were Sold to Success Healthcare LLC</strong><br /><br />To address its financial problems, Envision decided to sell its accounts receivable to a firm in Florida. Here is the rationale:<br /><blockquote>Less successful hospitals operate on razor-thin profit margins, waiting for slow-paying state and federal agencies to provide Medicaid and Medicare reimbursements. Such hospitals have difficulty obtaining financing and lack dependable cash flow.<br /><br />To provide support to a distressed hospital, the Florida partners would purchase its accounts receivables at a discount. For instance, if the government, a health insurer or patient owed a hospital for services, the partners would purchase that invoice for less money. The hospital, in turn, would have cash in hand.</blockquote>Note that "hospitals tend to avoid such cash-flow companies, because some of them use heavy-handed collection tactics." However,<br /><blockquote>For struggling Forest Park and St. Alexius, selling their accounts receivables was an alluring option. </blockquote>So,<br /><blockquote>Forest Park also was dogged by creditors and having difficulty making its payroll and paying utility bills.<br /><br />That’s when Envision began doing business with one of the Florida partners’ firms, <em>Sun Capital Healthcare Inc., which purchased $61 million in receivables from Forest Park and St. Alexius</em>.<br /><br /><em>When Envision defaulted on its sales agreement in September 2008, the Florida partners formed Success [Healthcare LLC] to purchase the two hospitals</em> for $39.5 million.</blockquote><br /><strong>The Promise of a Turn Around</strong><br /><br />To the public and the struggling hospitals, the purchase by Success Healthcare LLC seemed a promise of deliverance:<br /><blockquote>Eighteen months ago, the new buyers of Forest Park Hospital <em>vowed to revive the beleaguered institution.</em><br /><em><br /></em><br /><em>They voiced optimism that the once-thriving, 450-bed medical center could be saved by fresh capital and determined leadership. They seemed equally enthusiastic about their other acquisition — St. Alexius Hospital</em> in south St. Louis. Even the name of their company — Success Healthcare LLC — evoked the sense that better days were ahead.</blockquote><br />Also,<br /><blockquote>When Success Healthcare bought Forest Park Hospital in December 2008, company officials spoke of transitions, not cutbacks.<br /><br />In a statement, the company called Forest Park and St. Alexius hospitals important community assets, saying that it planned to enact a <em>'turnaround plan and financial strategy'</em> in the next six months “that will support the immediate and long-term objectives for the hospitals.'</blockquote><strong>The Actual Results</strong><br /><br />Better days were not ahead.  Instead, as summarized by the Post-Dispatch article,<br /><blockquote>But the three partners from South Florida were ill-prepared to make good on their words. In reality, they were already <em>deep in a financial scandal that involved the potential loss of more than $500 million in investor funds, the suicide of an investment manager in Bermuda, and allegations of fraud and self-dealing</em>.</blockquote><br />The mess resulted from the involvement of what became Success Healthcare LLC and an off-shore financier. First, here is some information on the history of the ironically named Success Healthcare LLC:<br /><blockquote>In recent years, [Peter] Baronoff, [Howard] Koslow and [Lawrence] Leder had built a small empire of health-related companies, whose holdings include at least 18 hospitals, and two finance firms. The firms share an office building at 999 Yamato Road in Boca Raton, Fla.<br /><br />Baronoff, <em>a former deputy mayor of Boca Raton, had worked as a wine and spirits importer</em>. Koslow had <em>experience in financial services and real estate</em>. Leder, <em>an accountant, was a former supervisory auditor for the U.S. General Accounting Office</em>.<br /><br />The partners marketed themselves as 'rescuing health care clients in financial emergencies,' including providers that file for bankruptcy protection or are considering such a filing.</blockquote><br />Then enter the off-shore financier:<br /><blockquote>Court records indicate that the Florida partners approached [William] Gunlicks in 1999 to invest in the health care receivables business. Two of the partners — Koslow and Baronoff — formed a Bermuda-based venture with Gunlicks in December 2009 called Stewards & Partners Ltd. to attract offshore investors.</blockquote><br />But between 1999 and December, 2009, things had had gone bad,<br /><blockquote>The first sign of serious problems appeared in April 2009, when the Securities and Exchange Commission filed a case against money manager William Gunlicks, a former Chicago banker whose investment funds provided hundreds of millions of dollars to the Florida partners to help finance their ventures. <em>The SEC accused Gunlicks of placing at risk about $550 million in investor funds,</em> including $5 million invested by the archdiocese of New Orleans.<br /><br />Soon after, <em>Gunlicks’ fund manager in Bermuda killed himself</em> with an overdose of pills, upset that he had lured investors to the troubled fund, according to media reports. Gunlicks, who declined to comment, <em>settled the SEC case — agreeing not to operate another investment fund.</em><br /><br />In July 2009, <em>a receiver appointed by a federal judge — whose mission is to recover Gunlicks’ investor’s money — sued the Florida partners’ finance companies for allegedly defaulting on loan payments to Gunlicks. The receiver accused the partners of fraudulently transferring hundreds of millions of dollars to purchase or prop up distressed hospitals that they owned. Investors also have sued the Florida partners.</em></blockquote><br />The troubles afflicting Success Healthcare LLC quickly affected the hospitals they had promised to save:<br /><blockquote>There are conflicting accounts about the financial strength of the Florida partners, but this is clear: They do not appear to have the wherewithal to operate Forest Park as a full-service hospital, and their financial troubles could also negatively affect St. Alexius, which reported in 2008 a bare-bones profit margin of 1.38 percent.<br /><br />Daniel Newman, the court-appointed receiver, has asserted that the Florida partners’ finance firms 'had long been insolvent ... and had been losing money.' He has accused them of overstating their revenues and assets to conceal at least $50 million in losses in recent years.</blockquote><br />The results on local health care were not good:<br /><blockquote>By April of this year, <em>Forest Park Hospital had laid off about three-quarters of its staff and reduced its operations to a small emergency department, 20-bed psychiatric ward, laboratory and pharmacy.</em><br /><br />'It’s a very dire situation,' said Dr. James Buford, president of the Urban League and a former member of the Forest Park Hospital’s board. 'It wouldn’t surprise me if the hospital went under. There hasn’t been a necessary infusion of capital to make it work.'<br /><br />Today, Forest Park Hospital is an almost empty landmark that overlooks the renovated Highway 40 (Interstate 64). The hospital is trying to use only one of its six floors and staffs a few dozen patient beds. Meanwhile, St. Alexius Hospital continues to offer a range of patient services, though it staffs only about one-third of its 456 licensed beds.</blockquote><br /><strong>Summary</strong><br /><br />First, I must admit that it is possible that the two St Louis hospitals could not have been maintained in their original configurations by even the most knowledgeable, dedicated, and visionary leadership. It may be that there location was untenable, given the growth of powerful competitors.<br /><br />However, it is hard to believe that the complex financial maneuvers in which they were caught up provided any benefits to patients, health care, or health professionals. Instead, it is likely that these maneuvers provided considerable personal gains to the people behind them (although these were not investigated in the St Louis Post Dispatch story).<br /><br />The big lesson: be very skeptical of glorious promises, especially those that come from new health care leaders who turn out to have no knowledge or background in health care. (Note that the leaders of Success Healthcare had no apparent background in actually providing health care, and no apparent commitment to the values health care professionals ought to support.) When you meet the new boss, assume at best he or she will be "same as the old boss," (to the lyrics of "Won't Get Fooled Again.")  We seem to be caught up in a business culture in which every new leader and fashionable management strategy is hyped and spun, and somehow people believe it all, forgetting how badly the previously hyped leaders and strategies crashed.<br /><br />How many times have we health professionals been told the new CEO, the new corporation taking over, the new business strategy will make everything better? How often has that been true? <br /><br />Health care desperately needs leadership that understand the context, and believes in the values.  The quick buck artists have been making themselves rich, while health care on the ground becomes poor.  How much money goes into the pocket of the clever leaders for their fancy financial maneuvers, rather than to provide patient care?  The answer might explain why US health care is the most expensive in the world, while primary care, and in this case, basic hospital acute care becomes less available.

The Failure of "Success Healthcare" - When Financial Maneuvering Takes Precedence Over the Health Care Mission

In the last few years, it seems that the whole world got tangled up in a web of complex financial dealings that mostly benefited those movin...

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Sanofi-Funded Society of Hospital Medicine Stands Up for Lovenox

Here is another case to raise questions about the true goal of some medical societies.  As <a href="http://online.wsj.com/article/SB20001424052748703900004575325023225623274.html">reported</a> by Alicia Mundy in the Wall Street Journal in late June, <br /><blockquote>A medical researcher and <em>two medical groups with financial ties to Sanofi-Aventis SA have asked federal regulators to hold off on approving generic forms of a Sanofi blood-thinner</em>....<br /><br />Citing potential patient safety issues, the head of the Society of Hospital Medicine and a medical researcher at Duke University last month sent letters to the Food and Drug Administration contending that Lovenox is too complex for any generic maker to copy fully.<br /><br />Earlier this year, another Sanofi-sponsored medical group, the North American Thrombosis Forum, sent two letters in favor of Sanofi's position opposing generic Lovenox. None of the letters mentions the signer's financial support from Sanofi.<br /><br />Two small drug companies, Amphastar Pharmaceuticals Inc. and Momenta Pharmaceuticals Inc., filed applications to the FDA in 2003 and 2005 respectively seeking to sell generic Lovenox, called enoxaparin.</blockquote><br />Of course, the two medical societies involved denied that there was any relationship between their support from Sanofi-Aventis and their concerns about the safety of biogeneric medications that might compete with a Sanofi-Aventis product (which, as the WSJ article noted, "had global sales of $4.57 billion in 2009").<br /><blockquote>Laurence Wellikson, chief executive of The Society of Hospital Medicine, which represents doctors who coordinate patient care, said his letter to the agency 'was <em>based entirely on the best evidence-based medicine available and the collective experience of SHM's senior hospitalists</em>.'</blockquote>Also<br /><br /><blockquote>Ilene Sussman, executive director of the North American Thrombosis Forum, said the group's doctors are concerned about generic Lovenox, and its letter was independent of Sanofi.</blockquote><br />The CEO of the SHM denied even a responsibility to disclose the Society's support from Sanofi-Aventis:<br /><blockquote>Dr. Wellikson said <em>it wasn't necessary to disclose that the group receives financial support from Sanofi because its letter 'focused on providing the best, most effective care to the hospitalized patient.'</em></blockquote><br />In fact, the SHM web-site includes a <a href="http://www.hospitalmedicine.org/Files/PDF/cmss/Industry_Support_Disclosure.pdf">"disclosure of organizational support" page</a> which suggests Sanofi-Aventis provided somewhere between $200,000 to $800,000 for three projects of the Society's projects, "pharmacoeconomics," "improving glycemic control," and "preventing VTE." The latter presumably could have something to do with anti-coagulants such as Lovenox. (The numbers are vague because the statement only discloses the amount of support provided in broad ranges.) Thus, support by Sanofi-Aventis could provide as little as 2.7% or as much as 11.1% of the Society's total income, which was noted to be $7,203,596 in its <a href="http://www.guidestar.org/FinDocuments/2009/233/057/2009-233057353-05ac90cc-9.pdf">2009 Form 990 </a>filed with the IRS, and publicly available via Guidestar.<br /><br />Given the broad <a href="http://www.hospitalmedicine.org/Content/NavigationMenu/AboutSHM/GeneralInformation/General_Information.htm">mission of the SHM</a><br /><blockquote>SHM is dedicated to promoting the highest quality care for all hospitalized patients. SHM is committed to promoting excellence in the practice of hospital medicine through education, advocacy and research.</blockquote>one wonders why it would want to get officially entangled in the approval process for specific biogeneric drugs.  If the leadership of the Society is so concerned about the safety of anti-coagulants, one wonders why they did not speak up about the case of the lethal contaminated heparin, about which we have blogged extensively, most recently <a href="http://hcrenewal.blogspot.com/2010/05/more-questions-no-answers-about-case-of.html">here</a>.  (I can find nothing on the web to suggest the Society, or Dr Wellikson, ever noted any concerns about this issue.)  Of course, that case involved heparin sold by Baxter International, whose production was out-sourced to a questionable supply chain.  SHM also receives support, amounting to something between 0 and $100,000, according to its "disclosure of organizational support" page, from Baxter International.  <br /><br />Thus it appears that the leadership of SHM was very concerned about the safety of an anti-coagulant manufactured by a competitor of Sanofi-Aventis which could threaten that company's revenues from the drug, while Sanofi-Aventis is one of the Society's major financial supporters.  On the other hand, the leadership seemed unconcerned about the safety of an anti-coagulant sold under the Baxter International label, while Baxter-International is also one of the Society's major financial supporters.  So it is hard to tell whether the leadership is more concerned about the safety of anti-coagulants, or the financial interests of the drug companies that support it.  <br /><br />The problem with the funding of health care professional societies by health care corporations that sell products or services that doctors can prescribe or order is that it raises the suspicion that such societies may use their considerable influence to serve the corporations', not patients' interests, and so undermine the professional values of the societies' members.  For this reason, Rothman et al suggested that such societies sever most of their financial ties to such corporations.(1)  (See our blog post <a href="http://hcrenewal.blogspot.com/2009/07/again-logical-fallacies-in-defense-of.html">here</a>.)  As long as the SHM chooses to accept support from drug and device companies, questions will be asked about the effects of such support on how the Society uses its influence.  Furthermore, assertions that such support is so irrelevant that the Society need not even disclose it will only fuel more suspicion.<br /><br />If ostensibly mission-driven not-for-profit health care organizations, like health care professional societies, but also including medical schools, academic medical centers, and patient advocacy groups, want the public and health care professionals to believe that they really are mission-driven, they need to spurn funding from organizations with vested interests whose service might distort these missions.<br /><br />Hat tip to Steve Lucas for his comment <a href="https://www.blogger.com/comment.g?blogID=9551150&postID=7625518709680137413&isPopup=true">here</a>.<br /><br /><span style="font-size: x-small;">References</span><br /><br /><span style="font-size: x-small;">1. Rothman DJ, McDonald WJ, Berkowitz CD et al. Professional medical associations and their relationships with industry. JAMA 2009; 301: 1367-1372. (Link </span><a href="http://jama.ama-assn.org/cgi/content/full/301/13/1367"><span style="font-size: x-small;">here</span></a><span style="font-size: x-small;">.)</span>

Sanofi-Funded Society of Hospital Medicine Stands Up for Lovenox

Here is another case to raise questions about the true goal of some medical societies.  As reported by Alicia Mundy in the Wall Street Jour...

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Jurassic Attitudes about Medical Informatics: in the U.S. Navy?

<style title="owaParaStyle">P { MARGIN-TOP: 0px; MARGIN-BOTTOM: 0px } BODY { SCROLLBAR-ARROW-COLOR: #3f52b8; SCROLLBAR-DARKSHADOW-COLOR: #fafafa; SCROLLBAR-BASE-COLOR: #f7f7f7; SCROLLBAR-HIGHLIGHT-COLOR: #cecfce; SCROLLBAR-TRACK-COLOR: #fffbff } </style><div dir="ltr" style="font-family:arial;"><span style="color: rgb(0, 0, 0);font-size:100%;" >The message below to a listserv for Chief Medical Informatics Officers and related positions was recently forwarded to me by a colleague. I cannot believe what I am reading, as it reflects attitudes I'd thought were extinct by the late 1990's ("I don't see the value of clinical informatics").<br /><br />The last time I'd heard such nakedly Jurassic views, and other anti-physician informatics attitudes <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/informaticsmd/tactics.htm">as in this 1999 essay</a> I penned, was from the C-level officers of the hospital where I was CMIO in that time frame, Christiana Care Health System in Delaware.<br /><br /><br /></span><blockquote><span style="font-size:100%;"><span class="undefined"><span style="color: rgb(0, 0, 0);">From: (Withheld)<span dir="ltr"></span><br />Date: Sun, Jul 4, 2010 at 9:24 AM<a href="http://www.blogger.com/redir.aspx?C=c4065bc8add74dd197a9b92ea9c445cf&URL=mailto%3aAMDIS%40home.ease.lsoft.com"></a></span><br /></span><br />Hi All,<br /><br />I was recently told by one of our senior leaders that </span> <span style="font-size:100%;"><strong>he saw no value to Clinical Informatics</strong> and followed that up by <span style="font-weight: bold;">disbanding the Clinical Informatics Directorate at the BUMED (Headquarters of Navy Medicine) level</span>.<br /><br />I successfully countered that argument with a more senior leader, but I tried to find objective evidence of the value of Clinical Informatics without success. As an academic family physician who lives, eats and breathes evidence-based medicine, I try to make all my decisions and arguments for and against positions/programs based on the best available evidence. In this case, all I could use was potential value and logic.<br /><br />My question is this: Does anyone out there (and I have already discussed</span> <span style="font-size:100%;">this with [<span style="font-style: italic;">name redacted - ed.</span>]) have any objective evidence that shows the value of clinical informatics to the Enterprise (which has multiple definitions, but suffice it to mean across an entire health care system.however large)? I have already talked with [<span style="font-style: italic;">name redacted - ed.</span>] about including a survey of CEO's/COO's/CMO's/CIO's as to the value they see in clinical informatics, but that is some time in the future. I really need some data now. Anyone have anything? Any and all assistance is greatly appreciated.<br /><br /></span><span style="font-size:100%;"></span></blockquote></div> <div dir="ltr" style="font-family:arial;"><span style="font-size:100%;"></span> </div> <div dir="ltr" style="font-family:arial;"><span style="font-size:100%;"><br />In the face of the apparent spectacular failure of AHLTA (<a href="http://hcrenewal.blogspot.com/2010/07/4-billion-military-emr-ahlta-to-be-put.html" target="_blank">$4 Billion Military EMR "AHLTA" to be Put Out of Its Misery? Also, Does the VA Have $150 Million to Burn on IT That Was Never Used?</a>), I certainly view such statements as extraordinary, and in a very negative sense.<br /><br />It has become my opinion that Jurassic attitudes about medical informatics are virtually <strong>unremediable</strong>; they suggest an underlying technical and mental deficit in those who proffer such opinions that is not correctible by evidence and logic. (I can predict with a good degree of certainty that this "senior leader" had a role in AHLTA's demise.)<br /><br /></span></div> <div dir="ltr" style="font-family:arial;"><span style="font-size:100%;"></span> </div> <div dir="ltr" style="font-family:arial;"><span style="font-size:100%;">I suggest a different approach: surely patients received suboptimal care (and perhaps suffered injury) under AHLTA. The freebie newspapers serving the soldiers such as I have seen in my visits to Fort Dix, where my mother has commissary/PX privileges as a result of my father's service-connected injuries and disability, might find such a story "interesting."<br /><br /></span></div> <div dir="ltr" style="font-family:arial;"><span style="font-size:100%;"></span> </div> <div dir="ltr" style="font-family:arial;"><span style="font-size:100%;">In the meantime, I am doing a <a href="http://en.wikipedia.org/wiki/John_Galt">John Galt</a> regarding persons espousing the "I don't see the value of informatics" view. I'm frankly tired that such people remain in the healthcare workforce. While I could provide a lot of material supporting the value of informatics (actually, its essential nature) that I and others have written over the years, I choose to no longer do so.<br /><br /></span></div> <div dir="ltr" style="font-family:arial;"><span style="font-size:100%;"></span> </div> <div dir="ltr"><span style=";font-family:arial;font-size:100%;" >The military person proffering this view is apparently a "senior leader"; it's their responsibility and indeed obligation to make the Navy better. Let them lead.<br /><br />And let the pieces fall where they may.<br /><br /></span><span style="font-size:100%;"><span style="font-family:arial;">-- SS</span></span><br /></div>

Jurassic Attitudes about Medical Informatics: in the U.S. Navy?

The message below to a listserv for Chief Medical Informatics Officers and related positions was recently forwarded to me by a colleague. ...

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